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Ministry of Health Approved Registration/Reregistration Application Form for Medicinal Products

Ministry of Health adopted the Order № 707 as of 30.10.2015 «On Amendments Introduction into the Regulation on Interaction between the Ministry of Health and State Expert Center» regarding the drafting of orders of the Ministry of Health of Ukraine on state registration (reregistration) of medicinal products (medicinal immunobiological products) and amendments introduction to registration materials, preparation and issuance of marketing authorizations».

The adoption of this order resulted mainly in approval of registration/reregistration forms for medicinal products.

Please note that the mentioned forms completely comply with the requirements of current legislation regarding the obligatory list of information which should be designated in the application for state registration/reregistration of medicinal products and does not provide for submission of any additional data.

Moreover, the order provides for the application form on adjustment of registration materials.

The approval of application forms with the fixed content shall minimize on the whole the risks of illegal refusal to business entities for state registration of the products due to formal issues.

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